Summary of Consolidated Financial Results [Japanese GAAP] For the Second Quarter of the Fiscal Year Ending March 31, 2021

On November 10, 2020 Nippon Kayaku reported that (Press release, Nippon Kayaku, NOV 10, 2020, View Source [SID1234571046])

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1. Consolidated Business Results for the Second Quarter of the Fiscal Year Ending March 31, 2021 (April 1, 2020–September 30, 2020)

(1) Consolidated Operating Results
(2) Consolidated Financial Position

2. Status of Dividends

3. Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2021 (April 1, 2020– March 31, 2021) (1) Significant changes in subsidiaries during the first half (changes in designated subsidiaries that result in changes in scope of consolidation): None

(2) Adoption of special accounting methods for presenting the quarterly consolidated financial statements: None
(3) Changes to accounting policies and estimates and restatements

[1] Changes to accounting policies associated with revision of accounting standards or similar items: Nippon Kayaku

[2] Changes other than
[1]: None

[3] Changes to accounting estimates: None

[4] Restatements: None

(4) Number of shares issued (common stock)

[1] Number of shares issued at end of the fiscal period (including treasury stock) As of September 30, 2020: 177,503,570 shares As of March 31, 2020: 177,503,570 shares

[2] Number of treasury stock at end of the fiscal period As of September 30, 2020: 6,710,248 shares As of March 31, 2020: 6,709,685 shares

[3] Average number of shares during the fiscal period (cumulative) First half of the fiscal year ending March 31, 2021: 170,793,635 shares First half of the fiscal year ended March 31, 2020: 173,144,521 shares * Quarterly summary financial statements are not subject to audit by a certified public accountant or audit firm. * Analysis related to appropriate use of the business forecasts, and other notes The information in this report constitutes forward-looking statements regarding future events and performance.

This information is based on the beliefs and assumptions of management in light of information currently available to it at the time of announcement and subject to a number of uncertainties that may affect future results. Actual business results may differ substantially from the forecasts herein due to various factors. For matters pertaining to business forecasts, please refer to "

(3) Analysis of Forward-looking Statements, Including Consolidated Business Results Forecasts" on page 3 of the Supplementary Information. (How to obtain the materials for the briefing on quarterly financial results) We have scheduled a teleconference for securities analysts and institutional investors on Wednesday, November 11, 2020. The materials for the briefing will be posted on the corporate website.

1. Qualitative Information Concerning Results for the Second Quarter

(1) Analysis of Operating Results During the first half of this consolidated fiscal year (April 1 to September 30, 2020), a deceleration in the global economy occurred from restrictions on economic activity to prevent the spread of the novel coronavirus. The increase in people infected with the virus led to restrictions on overseas travel, stay-at-home restrictions, and store closures in the U.S. and Europe from March onward, causing a slump in economic activity and a resulting rapid deterioration in the economy. However, signs of a gradual rebound were seen in consumer spending and corporate revenues. In China, the economy continued to recover as economic activity resumed. The Japanese economy saw improvement in consumer spending and corporate revenues, but the unpredictability of the timing for bringing the pandemic under control caused uncertainty over the future to persist. Amid these conditions, the Nippon Kayaku Group worked to implement the key themes and resolve the midand long-term key issues outlined in "KAYAKU Next Stage," the mid-term business plan launched in the fiscal year ended March 31, 2020, while also making active use of flextime, telecommuting, and other systems to accommodate the restrictions on corporate activity. We took these steps to ensure the safety of employees working in the Company and at Group companies while also implementing a new lifestyle and promote efficient workstyles aimed at minimizing the impact on our business.

As a result, net sales for the first half of this consolidated fiscal year totaled 80,518 million yen, a decrease of 5,089 million yen (5.9%) year-on-year. Sales in the functional chemicals and the pharmaceuticals businesses outperformed the first half of the previous fiscal year, while sales in the safety systems business declined. Operating income totaled 6,976 million yen, a decrease of 2,069 million yen (22.9%) year-on-year. Ordinary income totaled 7,341 million yen, a decrease of 1,807 million yen (19.8%) year-on-year. Profit attributable to owners of parent was 4,883 million yen, a decrease of 1,454 million yen (22.9%) year-on-year. Performance by business segment is as described below. [Functional Chemicals Business] Sales stood at 34,850 million yen, an increase of 709 million yen (2.1%) year-on-year. The functional materials business outperformed the first half of the previous fiscal year, despite a decline in vehicle-related sales.

This resulted from strong sales of epoxy resins used in semiconductor encapsulation and circuit boards due to increased demand for IT equipment such as high-speed (5G) communications devices and PCs. The color materials business underperformed the same period of the previous fiscal year due to slow sales of colorants for inkjet printers in industrial applications and dyes for textiles due to the impact from the spread of the novel coronavirus. Sales of colorants for inkjet printers for consumer use were firm due to telecommuting. The catalyst business outperformed the same period of the previous fiscal year, both in Japan and overseas. The Polatechno Group saw slow sales of dye-type polarizing films and other optical materials and components due to the impact from the spread of the novel coronavirus, underperforming the same period of the previous fiscal year. Segment profit rose to 3,647 million yen, an increase of 143 million yen (4.1%) year-on-year.

This resulted from growth in sales in the catalyst business, which more than covered the decline in sales of the color materials business and the Polatechno Group. [Pharmaceuticals Business] Sales stood at 25,134 million yen, an increase of 1,908 million yen (8.2%) year-on-year. Pharmaceuticals in Japan were impacted by two drug price revisions since the first half of last fiscal year. Nevertheless, the segment outperformed the first half of the previous fiscal year as growth in sales contributed to performance due to the switch to biosimilars and generic drugs, and growth in the antibody biosimilars, TRASTUZUMAB BS and INFLIXIMAB BS, in particular.

The new drug, APREPITANT capsules, also contributed to sales. Although sales of contract production outperformed the same period of the previous fiscal year, exports and sales of active pharmaceutical ingredients underperformed the same period of the previous fiscal year due to the impact from the spread of the novel coronavirus. Segment profit was totaled 4,334 million yen, an increase of 684 million yen (18.8%) year-on-year. This resulted from a decrease in sales-related expenses due to decreased sales activities as the novel coronavirus spread and growth in sales of antibody biosimilars. [Safety Systems Business] Sales stood at 16,989 million yen, a decrease of 7,082 million yen (29.4%) year-on-year. Sales of airbag inflators, micro gas generators for seatbelt pretensioners, and squibs underperformed the same period of the previous fiscal year owing to the slump in the automotive market in all regions outside of Chinaincluding Japan, under the impact from the spread of the novel coronavirus. A decline in sales due to the slump in the automotive market led to segment profit of 1,366 million yen, a decrease of 2,692 million yen (66.3%) from the same period of the previous fiscal year. [Other] Sales stood at 3,544 million yen, a decrease of 625 million yen (15.0%) year-on-year.

The agrochemicals business underperformed the same period of the previous fiscal year in both domestic sales and exports. Sales in real estate and other business increased compared to the first half of the previous fiscal year. Segment profit totaled 876 million yen, a decrease of 137 million yen (13.6%) year-on-year. Growth in real estate and other business sales did not cover the decline in sales in the agrochemicals business.

(2) Analysis of Financial Position

[1] Status of Assets, Liabilities, and Net Assets Total assets were 290,607 million yen, an increase of 12,111 million yen from the end of the previous consolidated fiscal year. The main increases were in securities, an increase of 10,389 million yen; investment securities, an increase of 2,792 million yen; and goodwill, an increase of 2,344 million yen. The main decreases were in cash and deposits, a decrease of 5,401 million yen; and merchandise and finished goods, a decrease of 2,935 million yen. Liabilities were 75,121 million yen, an increase of 6,644 million yen compared to the end of the previous consolidated fiscal year.

The main increase was in short-term loans payable, an increase of 9,462 million yen. The main decrease was in income taxes payable, a decrease of 2,018 million yen. Net assets were 215,485 million yen, an increase of 5,466 million yen compared to the end of the previous consolidated fiscal year. The main increases were in retained earnings, an increase of 2,321 million yen (a 2,561 million yen decrease from dividends paid and a 4,883 million yen increase in profit attributable to owners of parent); and unrealized holding gains on other securities, an increase of 1,936 million yen.

[2] Cash Flows Status Net cash provided by operating activities amounted to 11,879 million yen (versus a cash inflow of 15,746 million yen during the same period of the previous fiscal year). The positive cash flow was primarily generated from profit before income taxes of 7,108 million yen, depreciation and amortization of 6,019 million yen, and a decrease in inventories of 2,932 million yen. The above factors more than compensated for income tax paid of 3,172 million yen and a decrease in notes and accounts payable-trade of 1,187 million yen. Net cash used in investing activities totaled 12,762 million yen (versus a cash outflow of 10,450 million yen during the same period of the previous fiscal year).

The net outflow was mainly due to expenditures of 6,228 million yen for business acquisition and 6,001 million yen for the purchase of property, plant, and equipment. Net cash inflow in financing activities amounted to 5,677 million yen (versus a cash outflow of 5,167 million yen during the same period of the previous fiscal year). This mainly resulted from a net increase in short-term loans payable of 10,512 million yen, despite the cash outflow from dividends paid of 2,556 million yen and expenditures for repayment of long-term loans of 2,222 million yen. Reflecting the above cash flow performance, the balance of cash and cash equivalents at the end of the first half was 51,739 million yen (versus 51,297 million yen during the same period of the previous fiscal year), an increase of 5,076 million yen from the end of the previous fiscal year.

(3) Analysis of Forward-looking Statements, Including Consolidated Business Results Forecasts The future business environment surrounding the Nippon Kayaku Group still bears the risk of an economic slowdown despite signs of a recovery in the global economy, due to uncertainty over an economic downswing under the impact from the spread of the novel coronavirus and U.S.-China trade friction, among other factors.

The Japanese economy is still feeling the impact from the spread of the novel coronavirus and is being supported by monetary easing and the benefits from economic measures implemented by the Japanese government, but is expected to gradually improve from the second half of 2020. Under these conditions, the Nippon Kayaku Group will work to ascertain and respond globally to the changing conditions. We will endeavor to keep our employees safe, while also continuing efforts to minimize the significant impact of this infectious disease on the business results of the Nippon Kayaku Group. The Nippon Kayaku Group also aims to respond flexibly to changes in the business environment and pursue optimal use of operating capital to increase the shareholder value, as well as expand existing businesses in global growth markets, accelerate the development of new businesses and new products, and enhance profits. We examined recent economic trends and progress in operating performance in the first half of this consolidated fiscal year, and are disclosing the full-year consolidated business forecasts for the fiscal year ending March 2021 that were not disclosed previously. See the Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2021 that was published today for further details.

2. Quarterly Consolidated Financial Statements and Notes to Quarterly Consolidated Financial Statements

(2) Consolidated Statements of Income & Consolidated Statements of Comprehensive Income

(3) Consolidated Statements of Cash Flows

(4) Notes to Quarterly Consolidated Financial Statements (Notes Regarding Assumptions for the Going Concern)I. First half of the fiscal year ended March 31, 2020 (April 1, 2019–September 30, 2019)

1. Information on sales and profit (loss) by reportable segmentNote 1: "Other" indicates a business segment that is not included in the reportable segments, including the agrochemicals business and real estate business.

Note 2: The 3,180 million yen downward adjustment to segment profit reflects a negative 3,200 million yen in corporate expense not allocable to the reportable segments and 19 million yen in eliminations for intersegment transactions. The corporate expense is mainly a general and administrative expense that is not attributed to the reportable segments.

Note 3: Segment profit has been adjusted to correspond with the total operating income as shown in the consolidated statements of income.

2. Changes in reportable segments No items to report

3. Information concerning impairment losses on non-current assets, goodwill, etc. by reportable segment No items to report II. First half of the fiscal year ending March 31, 2021 (April 1, 2020–September 30, 2020)

1. Information on sales and profit (loss) by reportable segment2. Changes in reportable segments (Revision of the method for allocation of corporate expenses) From the first quarter of the consolidated fiscal year under review, the Company’s general and administrative expenses which has previously been allocated among the reportable segments, have been reclassified as corporate expenses. This was done to reflect the actual state of responsibility for management activities for the entire Group and to more accurately ascertain the performance of each reportable segment. This has resulted in increases in segment profit in the first half of the consolidated fiscal year under review of 1,541 million yen in the functional chemicals business, 905 million yen in the pharmaceuticals business, 907 million yen in the safety systems business, and 158 million yen in the other businesses, and a decrease of 3,512 million yen in adjustments to segment profit compared calculations under the previous method. The segment information provided for the first half of the previous fiscal year has been recalculated to show segment profit and loss after the revision.

3. Information concerning impairment losses on non-current assets, goodwill, etc. by reportable segment (Material change in the amount of goodwill) The acquisition of a business from Henkel AG & Co. KGaA in the functional chemicals business resulted in goodwill, increasing total goodwill by 2,602 million yen. (Additional Information) (Accounting estimates of the impact from the spread of the novel coronavirus) There are no significant changes to assumptions, including assumptions for the timing of bringing the novel coronavirus under control, noted in "Additional Information, Accounting estimates of the impact from the spread of the novel coronavirus" appended to the securities report for the previous consolidated fiscal year. (Significant Subsequent Events) (Company split from consolidated subsidiary (simple, abbreviated absorption-type split)) At its Board of Directors meeting held on March 31, 2020, Nippon Kayaku passed the following resolution for the Company to take over the business of manufacturing and selling polarizing films for LCDs, polarizing films for projectors, and other precision-processed products (hereafter, "the business") from its consolidated subsidiary, POLATECHNO CO., LTD. (hereafter, "Polatechno"), via an absorption-type split (hereafter, "the absorption-type split"), effective on October 1, 2020. Nippon Kayaku took over this business as scheduled on October 1, 2020.

1. Summary of transaction (1) Companies involved in the business combination and names and descriptions of the business The business of Polatechno, a wholly-owned subsidiary, in manufacturing and selling polarizing films for LCDs, polarizing films for projectors, and other precision-processed products

(2) Date of business combination Date of Board of Directors resolution approving the absorption-type split agreement (Nippon Kayaku): March 31, 2020 Date of Board of Directors resolution approving the absorption-type split agreement (Polatechno): March 27, 2020 Conclusion date of absorption-type split agreement: May 22, 2020 Date on which the absorption-type split agreement became effective: October 1, 2020 Note: This absorption-type merger constitutes an abbreviated split under Article 784, Paragraph 1 of the Companies Act for Polatechno, the company splitting off the business; and as a simple split under Article 796, Paragraph 2 of the Companies Act for Nippon Kayaku, the succeeding company. Both companies therefore executed the absorption-type split agreement without obtaining approval from the Shareholders Meeting.

(3) Legal form of business combination The form is an absorption-type split (simple absorption-type split) in which Polatechno is the splitting company and Nippon Kayaku is the succeeding company.

(4) Name of company after business combination There are no changes to the names, location of headquarters, capital, and fiscal year-end of either company as a result of this absorption-type split. However, the description of the main business of the split company after the absorption-type split was changed to the land leasing business. The accompanying amendments to the Articles of Incorporation for the split company were approved at the Annual Shareholders Meeting held on June 24, 2020.

(5) Other information concerning the summary of the transaction Incorporating the business into the Company as a business division will enable more effective use and optimal allocation of the management resources possessed by both companies, such as human resources, sales channels, production locations, and intellectual property. The Company is aiming to improve the efficiency of and expand the business by integrating the R&D structures of both companies to improve the efficiency and speed of R&D, strengthen governance, and achieve other benefits.

2. Summary of accounting standards implemented The Company accounted for the combination as a transaction under common control in accordance with ASBJ Statement No. 21, Accounting Standard for Business Combinations (January 16, 2019) and ASBJ Guidance No. 10, Implementation Guidance on Accounting Standard for Business Combinations and Accounting Standard for Business Divestitures (January 16, 2019). This absorption-type split was eliminated as an internal company transaction in the consolidated financial statements and it therefore had no impact on profit and loss.

HitGen Licenses Its Trk/ROS1 Inhibitor HG030 to Baiyunshan for Development and Commercialisation in China

On November 10, 2020 HitGen Inc. (HitGen, 688222.SH) reported it has entered into a collaboration and licensing agreement with Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd (Baiyunshan, 600332.SH/00874.HK) to develop and commercialise its HG030 programme in mainland China (Press release, HitGen, NOV 10, 2020, View Source [SID1234571035]). Baiyunshan is a publically listed company in Shanghai and Hong Kong engaged in the pharmaceutical and healthcare industry. HG030 is a novel inhibitor for Trk/ROS1 discovered by HitGen, which received IND approval from China’s National Medical Products Administration (NMPA) in March 2020, and is entering Phase I clinical trial in China for patients with NTRK/ ROS1 gene fusion-positive cancers.

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Under the terms of the agreement, Baiyunshan will receive exclusive rights for the development and commercialisation of HG030 in the mainland China, and will pay HitGen an upfront licensing fee of RMB 38M, followed by a series of milestones and royalty of sales as the product progresses through clinical trials and product launches in the mainland China. HitGen retains all rights of the product in all territories outside the mainland China.

HG030 is a second-generation small molecule Trk inhibitor designed to treat patients with NTRK gene fusion-positive cancers, regardless of cancer type. Most patients with NTRK-rearranged advanced cancer are sensitive to tyrosine kinase inhibitor (TKI) therapy. These TKIs have dramatically improved outcomes for patients with advanced Trk-positive cancer, yet these cancers remain incurable. Resistance invariably develops, such as acquired mutations G595R and G667C. HG030 is a novel, highly potent, selective, second-generation Trk inhibitor with clear activities in preclinical models against most known resistance mutations in patients with advanced Trk-positive cancer. Therefore, HG030 might be an effective therapeutic strategy for patients with Trk-positive advanced cancer who were naive or had become resistant to currently available TKIs.

"We are very pleased to enter this licensing agreement with Baiyunshan. Over the past few years, HitGen has been developing an innovative drug discovery technology platform centred on DNA-encoded libraries (DELs), and has entered into a number of research collaborations with leading pharmaceutical and biotechnology companies worldwide utilising this technology. In addition to the development and applications of DELs technology, we have also been applying our discovery research capabilities to build a portfolio of innovative drug discovery projects for collaboration and licensing. HG030 is the first out-licensing result of such an effort. This collaboration and licensing demonstrates HitGen’s capability in progressing discovery projects from target nomination to early clinical trials, as well as the quality of the programme. We hope our effort of this type will contribute to the discovery and development of innovative medicines for patients. With their tremendous clinical development, manufacturing and commercialisation capabilities and track record, I look forward to seeing further progress of HG030 in clinical development and ultimate successful product launch by Baiyunshan", said Dr Jin Li, Chairman and CEO of HitGen Inc.

BrickBio Announces Data on First Preclinical Antibody for Breast and Gastric Cancer

On November 10, 2020 BrickBio reported that in site-specific bioconjugation for improved therapeutics via its unnatural amino acid incorporation technology platform, reported that it has expanded on three therapeutic programs and received positive data on its first preclinical novel antibody-drug conjugate, BRKB-28, for breast cancer and gastric cancer (Press release, BrickBio, NOV 10, 2020, View Source [SID1234570981]). The data from a leading CRO that conducted the in vitro testing reported that BRKB-28 did not target nor adversely affect healthy cells, and at the same time eradicated the cancerous targets.

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BrickBio’s platform has the ability to precisely control the DAR (drug to antibody ratio) while producing a homogenous product. The tight control of the DAR contributed to a significantly improved performance profile of BRKB-28 over the leading breast and gastric cancer biologic, which resulted in significant death of healthy cells. Having the broadest and most diverse toolkit of bioconjugation handles, BrickBio is able to site-specifically modify any protein at any site, improving key therapeutic characteristics, such as increased half-life, increased efficacy, decreased dosage and decreased toxicity. Furthermore, the flexible BrickBio platform is payload and linker agnostic, expression host agnostic and produces an entirely homogenous product in every conjugation.

Preclinical Antibody for Breast and Gastric Cancer

The flexibility of the BrickBio platform has enabled the expansion of the company’s therapeutic programs, including "Antibody Drug Conjugates", "Novel Bispecific Antibody Conjugates", and "Novel Scaffolds".

"In addition to ongoing partnerships for technology licensing and co-development of partners’ preferred molecules, we are rapidly building on the breadth of capabilities of the BrickBio platform and expanding our internal pipeline for novel biologics," said Audrey Warner, Head of Business Development at BrickBio and Vice President of Investments at Tiger Gene. "BrickBio will partner on its novel-specific pipeline assets as it continues to expand its therapeutic programs," Warner concluded.

"It is very promising to see the facile integration of our unique bioconjugation platform into any protein scaffold, as validated with our BRKB-28 candidate," said James Italia, VP of Commercial Development at BrickBio. "Our team is able to quickly generate and screen candidates with a variety of scaffolds, linkers, and payloads with exquisite control over their biophysical characteristics. We are already witnessing the benefit of the BrickBio advantage and look forward to future candidates in our other internal programs."

"The robustness and flexibility of the BrickBio platform has enabled the company to progress at a much faster rate than initially forecasted, in terms of developing novel antibody drug conjugates, protein therapeutics, and novel bispecific antibody conjugates," said John Boyce, Co-Founder, Chairman, President and CEO of BrickBio, and Co-Founder of Tiger Gene. "We are not only excited about our first pre-clinical candidate for breast and gastric cancer, but also about the continued work with our pharmaceutical partners to rapidly expand the pipeline across a number of indications," Boyce concluded.

Bioheng Announced Oral Presentation of Its Preliminary Results of CRISPR-Engineered Allogeneic CAR-T for r/r B-ALL Treatment at 2020 ASH Meeting

On November 10, 2020 Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company focuses on developing novel cellular immunotherapy, reported that their preliminary data including the pre-clinical development, manufacturing, and investigator initiated trial (IIT) results for CTA101, a CRISPR/Cas9-engineered off-the-shelf CD19/CD22 dual-targeted CAR-T cell product, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held virtually on December 5-8, 2020 (Press release, Bioheng Biotech, NOV 10, 2020, View Source [SID1234570980]). The study was designed to evaluate the feasibility of CTA101 in patients with relapsed/refractory B-cell acute Lymphoblastic Leukemia (r/r B-ALL).

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"CTA101, a CRISPR-engineered allogeneic dual-targeted CAR-T, has showed manageable safety and promising efficacy in the treatment of r/r B-ALL patients," said the PI of this study, He Huang, MD, PhD, Professor of hematology, President of The First Affiliated Hospital, Zhejiang University School of Medicine. "It has preliminarily verified the feasibility of generating allogeneic CAR-T by CRISPR gene editing and provided evidence for extended application in the future. As an allogeneic CAR-T, CTA101 tackles several limitations associated with conventional CAR-T therapy, such as possible manufacturing failures, undesirable waiting period between leukapheresis and CAR-T infusion, poor product consistency due to bespoke manufacturing process for individual patient, and unaffordable cost. In addition, its dual-targeted design may be a viable solution to reduce the relapse rate of B-ALL. I would like to expect more allogeneic CAR T cell products for clinical use, which certainly provide more choices to address the unmet medical needs."

Oral Presentation

Title: 499 The Safety and Efficacy of a CRISPR/Cas9-Engineered Universal CAR-T Cell Product (CTA101) in Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Session: 801. Gene Editing, Therapy and Transfer I
Date: Sunday, December 6, 2020
Time: 2:30 p.m. ET (11:30 a.m. PT)
View Source

"We are looking forward to sharing initial data on the feasibility, safety and efficacy of our first allogeneic CAR T cell product, CTA101, at the ASH (Free ASH Whitepaper) 2020 annual meeting," said Xiaohong He, PhD, CEO of Bioheng Biotech. "CTA101 is based on our first-generation allogeneic CAR T technology platform, which can be timely infused to patients without HLA matching. Bioheng has always been committed to the development and commercialization of allogeneic CAR-T cell technologies and products. The positive results of CTA101 will further promote the development and translation of our multiple allogeneic CAR T pipelines."

Anaveon announces presentation at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 10, 2020 Anaveon, an immuno-oncology company, reported that it will present a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Virtual Annual Meeting being held from Monday, November 9, 2020 to Saturday, November 14, 2020 (Press release, Anaveon, NOV 10, 2020, View Source [SID1234570895]).

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The abstract is available on the SITC (Free SITC Whitepaper) website and the accompanying poster will be available in the Virtual Poster Hall open from 8.00 a.m. EST on Monday, November 9, until the Virtual Poster Hall closes on December 31, 2020 and is also available on Anaveon’s website.

ANV419, Anaveon’s lead programme, is a powerful and selective interleukin-2 (IL-2) agonist that is in late stage preclinical development for the treatment of cancer. It represents a unique approach to no-alpha IL-2 agonists by taking advantage of a highly selective antibody which binds to the same site as the IL-2 alpha receptor and is able to completely abolish its binding.

The data demonstrates that ANV419 presents IL-2 to the beta/gamma IL-2 receptor with similar potency as native IL-2 and thus provides a natural growth signal to anti-tumor CD8+ T cells and natural killer (NK) cells while it avoids promoting pro-tumor regulatory T cells. The compound is a high molecular weight biologic that behaves like an antibody and has an outstanding safety profile in non-human primates.

"We are excited by the data demonstrating that ANV419 has a unique approach to no-alpha IL-2 agonists by taking advantage of a highly selective antibody which binds the same site as the alpha receptor and is able to completely abolish its binding," said Christoph Huber, Chief Scientific Officer of Anaveon. "With its high level of activity on anti-tumor immune cells and excellent safety profile we look forward to starting our first clinical study in Q1 2021 and to exploring ANV419’s applicability in a range of cancer indications, as well as in combination with other therapeutics."

Details of the poster presentation:

Title: ANV419 is a novel CD122-selective IL-2/anti-IL-2 antibody fusion protein with potent CD8 T cell and NK cell stimulatory function in vitro and in vivo

Live Q&A: Poster #571 – Wednesday, Nov. 11 from 5:15-5:45 p.m. EST and Friday, Nov. 13 from 4:40-5:10 p.m. EST

Anaveon was founded in December 2017 by Andreas Katopodis, previously Director at the Autoimmunity, Transplantation & Inflammation Group at the Novartis Institutes for BioMedical Research and Onur Boyman, Professor and Chair in the Department of Immunology at the University of Zurich. The Company is developing selective IL-2 Receptor Agonists, a type of protein that could therapeutically enhance a patient’s immune system to respond to tumors. In the body, human IL-2 stimulates a type of immune cell, called a T-cell, to multiply and become activated. Under certain situations, T-cells are able to attack tumors and, consistent with this, human IL-2 is already approved as a therapeutic for the treatment of metastatic melanoma and renal cancer. The lead compound, ANV419, is designed to overcome known challenges with human IL-2. These include severe, dose-limiting side effects and a short half-life that requires frequent infusions. This type of drug, if approved, could potentially have a wide utility in oncology, including in combination with cell therapies, vaccines, checkpoint inhibitors and radiotherapy.